Effectiveness of Transcranial Direct Current Stimulation (tDCS).

NCT04902274 | Terminated

• 1 other identifier: 19KACH005
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Reducing pain and recovery of strength and function are major challenges in physical therapy. Transcranial direct current stimulation (tDCS) is a novel intervention that has gained popularity in the rehabilitation of athletic injuries, pain management, and sports performance. Acute application of tDCS has been shown to modulate the perception of effort and fatigue, enhance motor learning, improve endurance performance, and improve muscular power and strength. tDCS has also been shown to reduce pain in patients with chronic pain conditions. Using a double-blind, randomized clinical trial design, we aim to evaluate the effectiveness of tDCS plus standard rehabilitation compared to rehabilitation alone on pain, balance and proprioception, functional performance, and strength following acute ankle inversion sprain. We hypothesize that the group using tDCS will demonstrate superior outcomes in all variables of interest.

Conditions

Ankle Sprains; Musculoskeletal Injury

Outcome Measures

Primary Outcomes (2)

• Composite Pain Rating

  Numerical Pain Rating Scale assessment of Current, Best 24-hour, Worst 24-hour Pain

  Change from Baseline to 4-weeks

• Composite Pain Rating

  Numerical Pain Rating Scale assessment of Current, Best 24-hour, Worst 24-hour Pain

  Change from Baseline to 8-weeks

Secondary Outcomes (10)

• Self-Reported Function

  Change from Baseline to 4-weeks

• Self-Reported Function

  Change from Baseline to 8-weeks

• Muscle Strength

  Change from Baseline to 4-weeks

• Muscle Strength

  Change from Baseline to 8-weeks

• Proprioception

  Change from Baseline to 4-weeks

Study Arms (2)

Transcranial Direct Current Stimulation plus Physical Therapy

EXPERIMENTAL

Participants in the experimental group will receive the current standard of care in ankle inversion sprain rehabilitation plus a 20-minute application of tDCS during each treatment session via the Halo Sport (Halo Neuroscience, San Francisco, CA) headset. The rehabilitation program will be standardized among all patients and will consist of therapeutic exercises, manual physical therapy, and other modalities. Rehabilitation sessions will be performed 2x weekly and sessions will last approximately 45 to 60 minutes.

Other: Transcranial Direct Current Stimulation; Other: Physical Therapy

Sham Transcranial Direct Current Stimulation plus Physical Therapy

SHAM COMPARATOR

Participants in the sham control group will receive the current standard of care in ankle inversion sprain rehabilitation plus a 20-minute sham tDCS treatment, where the patient is wearing the tDCS headset, but stimulation is only applied for 30 seconds of the 20-minute period. The rehabilitation program will be standardized among all patients and will consist of therapeutic exercises, manual physical therapy, and other modalities. Rehabilitation sessions will be performed 2x weekly and sessions will last approximately 45 to 60 minutes.

Other: Sham Transcranial Direct Current Stimulation; Other: Physical Therapy

Interventions

Transcranial Direct Current Stimulation OTHER

The Halo Sport (Halo Neuroscience, San Francisco, CA) is a commercial off-the-shelf tDCS device that delivers a 2.2 mA current to the motor cortex through three elastomer foam scalp pads with a 24 sq. cm surface area (see https://www.haloneuro.com/). The tDCS is controlled through the Halo Sport App where the therapist and patient are blind to an actual or sham treatment. Patients in the tDCS group will complete a 20-minute tDCS session while performing the warm-up.

Transcranial Direct Current Stimulation plus Physical Therapy

Sham Transcranial Direct Current Stimulation OTHER

The Halo Sport (Halo Neuroscience, San Francisco, CA) is a commercial off-the-shelf tDCS device that delivers a 2.2 mA current to the motor cortex through three elastomer foam scalp pads with a 24 sq. cm surface area (see https://www.haloneuro.com/). The tDCS is controlled through the Halo Sport App where the therapist and patient are blind to an actual or sham treatment. Patients in the sham tDCS group will complete a 20-minute sham-tDCS session while performing the warm-up, but the app will discontinue the treatment after 30 seconds.

Sham Transcranial Direct Current Stimulation plus Physical Therapy

Physical Therapy OTHER

After the tDCS session is complete, the patient will complete treatment consistent with the standard of care for rehabilitation of acute ankle inversion sprain. The rehabilitation program will be standardized among all patients and will consist of therapeutic exercises, manual physical therapy, and other modalities. Rehabilitation sessions will be performed 2x weekly and sessions will last approximately 45 to 60 minutes. Patients will also perform a standardized home exercise program that reinforces the in-clinic treatment.

Sham Transcranial Direct Current Stimulation plus Physical Therapy; Transcranial Direct Current Stimulation plus Physical Therapy

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-40
• Within 2-weeks s/p acute grade 1 or 2 ankle inversion sprain

You may not qualify if:

• Self-Reported Pregnancy
• Being treated for and on medication for a mental health diagnosis
• Concussion or non-lateral ankle sprain lower extremity injuries within the past 6 months
• Open wound or dermatologic lesion on the head or region of application
• Active implantable medical devices such as cochlear implants or cardiac pacemakers, or with metal implants in the head (excluding standard orthodontic braces, fillings, etc.).
• Epilepsy or history of seizures
• Participants who are not fluent in English

Sponsors & Collaborators

• Keller Army Community Hospital: lead

Study Sites (1)

Keller Army Community Hospital - Arvin Physical Therapy

West Point, New York, 10966, United States

Location

MeSH Terms

Conditions

Ankle Injuries

Interventions

Transcranial Direct Current Stimulation; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 26, 2021
• Study Start: August 19, 2020
• Primary Completion: December 17, 2021
• Study Completion: December 17, 2021
• Last Updated: April 28, 2022

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)